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RJR suing over rights
FDA limits on ads, products, packaging violate 'free speech'
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Published: September 1, 2009
Updated: 08/31/2009 11:40 pm
R.J. Reynolds Tobacco Co., as expected, is suing the federal government and the Food and Drug Administration in an attempt to carve out a "free speech" marketing niche for innovative products.
Reynolds was joined yesterday in the lawsuit by Conwood Co. LLC, a sister company with Reynolds American Inc., Lorillard Inc. and Commonwealth Brands Inc.
The lawsuit was filed in federal court in Bowling Green, Ky. Also named was the FDA commissioner and secretary of the U.S. Health and Human Services Department.
The manufacturers said they are trying to "protect their First Amendment right to communicate with adult tobacco consumers about their products."
Charles Miller, a spokesman for the U.S. Attorney General's Office, said that the government would not have any comment until it had a chance to review the lawsuit.
In June, the FDA was granted the power to regulate the content of tobacco products.
That included removing ingredients considered as hazardous; restricting the marketing and distribution of cigarettes and smokeless tobacco; focusing on limiting the impact of advertising on youth; expanding warning labels; and stopping the use of such characterizations as "light" or "low tar."
The manufacturers involved in the lawsuit opposed FDA regulation, and Altria Group Inc., the largest U.S. tobacco manufacturer, was in favor. Reynolds suggested in June that it would target the marketing and distribution aspects of the new law in any potential legal action.
"Prior to the passage of the act, existing federal and state laws already severely restricted plaintiffs' ability to speak truthfully and freely to adult tobacco consumers," according to the lawsuit. "The act now adds layer upon layer of additional restrictions, thereby virtually eliminating the remaining few avenues for protected speech."
For example, FDA regulation places a warning label or message on the top half of a cigarette package. The manufacturers said in the lawsuit that the label would make cigarette branding difficult to see and impair the value of their trademarks.
Martin Holton III, the general counsel for Reynolds, stressed that the lawsuit "does not challenge Congress' decision to give the FDA regulatory authority over tobacco products, nor does it challenge the vast majority of the provisions of the new law." He said that Reynolds plans to work with the recently created Center for Tobacco Products of the FDA.
Another reason for the lawsuit is that Reynolds has placed a major emphasis on smokeless tobacco products to help offset the continuing decline in cigarette sales in the United States.
The law requires premarket approval for new products, those introduced after Feb. 15, 2007.
Some analysts have said that requirement would severely curtail product innovation.
However, Adam Spielman, an analyst with Citigroup Global Markets Inc., said he believes that regulation will not undercut Reynolds' smokeless innovations. "The rules on new products do not require sign-off from the FDA if the product is substantially equivalent health-wise to existing products," he said.
Camel Snus were introduced before February 2007, said Maura Payne, a spokeswoman for Reynolds. "There were also substantially equivalent snus products sold in the United States prior to Camel Snus," she said.
Payne said that the orbs, sticks and filmlike strips for the tongue are substantially equivalent to dissolvables sold by Star Scientific Inc.'s Ariva and Stonewall.
Holton said that the manufacturers participating in the lawsuit believe that "governments, public health officials, tobacco manufacturers and others can and should play a role in providing adult tobacco consumers with accurate information about the various health risks and comparative risks associated with the use of different tobacco and nicotine products."
"This lawsuit seeks to confirm that Reynolds' ability to participate in that important dialogue has not been shut down."
Dr. John Spangler, a professor of family and community medicine at Wake Forest University School of Medicine, said that the "consensus view about the new products is that they are still harmful."
"The issue of comparative risk is not accepted by most of the scientific community because tobacco still is a carcinogen no matter in what form it is consumed," Spangler said.
"I guess the real crux of the matter is accurate information. People are going to be suspicious about the accuracy of the information put forth by tobacco companies as part of their participation in the broader public dialogue."
Other plaintiffs in the case are National Tobacco Co. L.P. and Discount Tobacco City & Lottery Inc., a tobacco retailer.
■ Richard Craver can be reached at 727-7376 or at rcraver@wsjournal.com.
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